Improving Ethical Practices Associated with Re-Use of Existing Stem Cell Lines in Australia

Improving Ethical Practices Associated with Re-Use of Existing Stem Cell Lines in Australia

Rachel Ankeny¹, Dianne Nicol³, Christine Wells⁴, Joan Leach², Edilene Lopes McInnes¹, Dan Santos², Mengqi Hu⁴, Michail Ivanov¹, Rebekah Harms¹, School of Humanities, University of Adelaide Adelaide², Canberra ACT³, TAS Australia^Parkville, Australia

¹School of Humanities, University of Adelaide, Adelaide, SA, Australia
²Australian National Centre for the Public Awareness of Science, Australian National University, Canberra, ACT, Australia
³Faculty of Law, University of Tasmania, Hobart, TAS, Australia
⁴School of Biomedical Sciences, University of Melbourne, Parkville, VIC, Australia

Abstract

Over 30,000 induced pluripotent stem cells (iPSC) have been registered in global databases such as Cellosaurus, many which are modified versions of the same parental cell line. While generation of the founding stem cell line requires ethical oversight, the sharing, modification, and use of stem cell lines may not. Re-use of existing stem cell lines is growing rapidly due to increased use of commercial or other existing lines as originally generated or in modified forms. There has been greater international attention to recommendations and best practices to improve the rigor and reproducibility of stem cell research, particularly associated with quality standards for characterisation of tissues, pluripotent human stem cells, and in vitro models based on them, and to sharing practices given the rapid rise of open science. We explore a series of questions associated with regulation as well as scientific and institutional practices in this domain in Australia in order to propose improvements to experimental practices and to better align re-use with public and donor expectations, using our empirical research findings on regulations, practices, and expectations. First, we consider whether re-use of existing stem cell lines is subject to ethics review under current Australian ethics regulations, including how we should understand what counts as human subjects research and how risks to donors should be gauged. We also explore how donor consent to re-use is tracked and determined, and whose responsibility such processes are and should be. Finally, we propose a positive model for best ethical practices associated with re-use of existing stem cell lines that will permit greater alignment of expectations, more attention to potential benefit sharing, improved acknowledgement of donor and researcher contributions, and higher quality stem cell research with clear health benefits.

Biography

Rachel A. Ankeny is an interdisciplinary teacher and scholar who is Professor of History and Philosophy at the University of Adelaide. Her areas of expertise cross several fields: history/philosophy of science, bioethics and science policy, and food studies. She also is an Honorary Visiting Professor in the College of Social Science and International Studies (Philosophy) at the University of Exeter (UK). She is the former vice president of the Australasian Association of Bioethics and Health Law.